Staying ahead of the CTR: What the new transparency rules mean

Xandra Neuberger, associate director, regulatory affairs and international service lead for clinical trial applications at PharmaLex, provides an Expert View.

There has been a continuous flow of new guidance documents and updates since the Clinical Trials Regulation (CTR) and accordingly adapted European Union Member State (MS) law became applicable on January 31, 2022. New information is communicated through different channels by the European Commission (EC), European Medicines Agency (EMA), Heads of Medicines Agencies (HMA) and the individual member states (MS), making it hard to keep track of relevant regulatory intelligence. 1 , 2 , 3

With so much information to juggle, companies conducting clinical trials in the EU need to find ways to stay on top of relevant recommendations and requirements so they can plan appropriately.